-
Quality System Associate
2 days ago
Meridian Bioscience North Billerica, United StatesAbout Meridian: · Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, acc ...
-
Director, Quality Systems
6 days ago
Lantheus North Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
-
Director, Quality Systems
4 days ago
Lantheus North Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
-
Director, Quality Systems
1 week ago
Lantheus Medical Imaging Inc North Billerica, United StatesJob Description · Job DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care wi ...
-
Sr. Quality Systems
1 week ago
Meridian Bioscience North Billerica, United StatesAbout Meridian: · Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, acc ...
-
Principal Software Systems Quality Engineer
1 week ago
RTX Tewksbury, United StatesDate Posted: · Country: · United States of America · Location: · MA133: Tewksbury, Ma Bldg 3 Concord 50 Apple Hill Drive Concord - Building 3, Tewksbury, MA, 01876 USA · Position Role Type: · Onsite · About Us : · At Raytheon, the foundation of everything we do is rooted ...
-
Quality Systems
1 week ago
Randstad Life Sciences Norwood, United StatesJob Description · Job DescriptionImmediate opportunities for Quality Systems & Distribution Specialists to support the QA Central Services Team. Do you have a strong QA / GMP background to support with documentation release process, and working with CMOs / CDMOs? This position is ...
-
Manager, Quality Systems Engineering
1 week ago
Analog Devices Wilmington, United StatesAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized facto ...
-
Quality System Supervisor
1 week ago
BostonGene Waltham, United StatesPosition Summary · BostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations ...
-
Quality Systems Analyst
2 days ago
Resonetics Nashua, United StatesThe Quality System Analyst plays a pivotal role in ensuring the quality and compliance of the quality management system, overseeing the creation and maintenance of key quality metrics, data analytics, and quality business processes within our organization. This position supports ...
-
Quality System Manager
2 weeks ago
BlackTree Technical Group, Inc. Sudbury, United StatesQuality Systems Manager · SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: · • Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements). · • Manage Document Contro ...
-
Quality System Specialist
3 weeks ago
eTeam Cambridge, United StatesTitle: Quality Systems Specialist · Location: Cambridge, MA · Duration: 6 Months · ON-SITE - 9 am - 5 pm / Monday - Friday · Pay Rate: $55.66/hr on W2 All Inclusive · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Qua ...
-
Manager, Supplier Quality Systems
1 week ago
Insulet Corporation Acton, United States Full timeInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative ...
-
Quality Systems Engineer
4 weeks ago
Experis Stoneham, United StatesJob Title - Quality Systems Engineer · Our client in Stoneham, MA (Hybrid; 2 - 3 days) is looking for hardworking, motivated talent to join their team. Looking for a candidate who canassist Stoneham site with implementation of Quality agreements and Change Commitments with relev ...
-
Quality Systems Specialist
2 weeks ago
Nuvalent, Inc. Cambridge, United StatesThe Company:With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a ...
-
Quality Systems Specialist
2 weeks ago
LanceSoft Cambridge, United StatesPosition Title: Quality Systems Specialist · Location: Cambridge, MA 02142 · Duration: 7 Months · Onsite - 9 AM - 5 PM / Monday - Friday · Job Description: · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality M ...
-
Manager, Quality Systems
1 week ago
Quest Diagnostics Marlborough, United StatesOverview: · Manage the quality management system and regulatory requirements for Quest Diagnostics to comply with all applicable regulations and standards including but not limited to FDA CFR Part 820 (QSR), ISO Quality Systems), ISO Risk Management), IVDR 2017/746 (In-Vitro Dia ...
-
Quality Systems Specialist
3 weeks ago
Randstad Life Sciences US Cambridge, United States*6-month contract with the potential to extend* · 100% on-site in Cambridge, MA · 9AM-5PM Shift · Job Description · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining ...
-
Quality Systems Specialist
4 weeks ago
The Accuro Group Inc Cambridge, United StatesBusiness Title: | Quality Systems Specialist · Location: Cambridge, MA 02142 · Job Type: Contract (7 Months) · Note: Parking will not be reimbursed by the CLIENT. Nearby garage parking is available for roughly $420/month. · Important: On Site / 9am-5pm / Monday – Friday. · J ...
-
Director, Quality Systems
1 hour ago
Apex Systems Cambridge, United StatesDirector, QualitySystems (eQMS Veeva · Location: Boston,MA(Hybrid / Onsite) · Therapeutic Area: Small molecule Pharma · Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance wi ...
Director, Quality Systems - North Billerica, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of RoleThis role is responsible for leading Lantheus' Quality Systems & Compliance team.
This role will oversee the global compliance function and related processes, providing multi-site oversight of laboratory, manufacturing, and distribution operations.
Manages and provides direction to Quality Systems, Compliance and Product Quality Complaints staff, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations governing drug products and medical devices.
This role will partner with various internal and external cross-functional teams as well as external regulatory and auditing agencies.Key Responsibilities/Essential Functions
Oversees the management of the Quality Systems & Compliance team supporting product quality complaints, post market surveillance, Annual Product Quality Reports, field alerts, recalls, internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, and Quality Management Review (QMR).
Process owner for Quality Systems Management processes including Quality Events, Deviation, Non-Conformance, CAPA, Change Control, Complaint Investigations, Document Control, and Training.
Lead or actively participate in implementation of updates and enhancements to these processes.Provide project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
Partner with the IT organization to manage initiatives related to Quality Management Systems.Responsible for inspection readiness and manage regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites.
Provides corporate training on inspection readiness, inspection process and best practices. May act as key liaison for local, state, federal, and global regulatory agency inspections.Develops and manages the internal auditing program to ensure a constant state of compliance.
Plans and executes compliance audits of internal operations as they relate to GxPs to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions.
Track and trend multi-site compliance issues to assure alignment with corporate standards.Responsible for the Compliance Surveillance program, tracking and trending new and changed regulations, agency guidance documents, industry standards, etc., identifying impact to Lantheus and driving resolution to close gaps.
Respond in a timely manner to compliance concerns and contribute to problem resolution.Responsible for the drug Product Quality Complaint and medical device Post Market Surveillance processes, activities, and teams, including Field Actions and Recalls.
Drives formal submission of FDA Field Alert Reports (FAR) and medical device reporting.Provides quality compliance oversight of Pharmacovigilance (PV) to ensure Adverse Event, complaint management and post market surveillance are executed compliantly and in a timely manner.
Manages the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and communication of results expediently to applicable groups.
Identify areas of improvement and participate in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives. Create new processes aimed at continual improvements, supporting a LEAN company culture. Manage multiple projects, realigning resources, and priorities to meet challenging timeframes.Responsible for driving functional excellence though the tactical execution of improvement activities.
Manages the range of performance management processes for direct reports. Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership.
Manage the budgeting process for the Quality Systems & Compliance function, and ensure expenditures align with budget.
Other duties as assigned.
Basic Qualifications
Bachelor's degree in a related medical, science or business discipline and minimum 15+ years' functional experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries; or equivalent combination of education and experience.
Previous people management and/or team leadership experience required.
Demonstrated cross functional leadership skills, with ability to lead and develop teams.
Other Requirements
Strong planning and project management skills; demonstrated ability to influence and gain commitment from others.
Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies as well as customers.
Ability to communicate effectively at all levels of the organization, as well as teach and present complex and/or new ideas with clarity and simplicity.
Must be detail oriented with the ability to multitask and respond to ever changing priorities.Ability to work independently, influence with or without authority, facilitate groups with diverse perspectives and bring teams to consensus/alignment.
Core Values:
The ideal candidate will embody Lantheus core values:
Let people be their best
Respect one another and act as one
Learn, adapt, and win
Know someone's health is in our hands
Own the solution and make it happen
#LI-HYBRID
#J-18808-Ljbffr
